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Pharmacovigilance Associate / Senior Pharmacovigilance Associate

2+ years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Full Time Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Advanced degree preferred) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Pharmacovigilance Associate / Senior Pharmacovigilance Associate
Job Reference: JR127208
Location: Chennai (Full Service & Corporate Support Office or Home-Based)
Department: Drug Safety
Employment Type: Full-time


About ICON plc

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are committed to innovation, inclusion, and excellence in clinical development, providing employees with an inclusive environment that supports professional growth and success.


Role Overview

As a PV Associate or Sr PV Associate, you will play a key role in managing and analyzing safety data for pre- and post-marketed products, ensuring compliance with global pharmacovigilance regulations and client-specific procedures.


Key Responsibilities

Safety Case Processing & Review

  • Review and process safety events (pre-marketing, post-marketing, medical devices, and drugs)

  • Perform literature surveillance (abstract/full article reviews) to identify relevant safety information

  • Perform safety review of clinical and diagnostic data

  • Generate accurate data listings from safety databases

Safety Communication & Documentation

  • Complete follow-up activities via phone or written communication with reporters/sites

  • Maintain project safety tracking systems and ensure data accuracy

  • Liaise with investigational sites, sponsors, and ICON stakeholders on safety matters

Project Management & Oversight

  • Assist in the development and maintenance of Safety Management Plans (SMP)

  • Contribute to creation of PSMF, RMP, and PBRER documents

  • Participate in safety data reconciliation and interim data analysis for DMC reviews

  • Attend project meetings, sponsor calls, and investigator meetings as needed

Regulatory Reporting & Signal Detection

  • Support the generation of aggregate safety reports (DSUR, IND Annual Reports, PSUR, etc.)

  • Assist Safety Scientists in signal detection and risk management activities

  • Identify out-of-scope project activities and recommend solutions

Compliance & Quality Assurance

  • Ensure safety database is maintained with high quality and accuracy

  • Support audit and inspection readiness and participate as required

  • Respond to medical information inquiries, including those related to AEs and product complaints


Candidate Profile

Qualifications:

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Advanced degree preferred)

Experience:

  • Prior experience in pharmacovigilance, drug safety, or related clinical/pharmaceutical areas

  • Familiarity with global PV regulations and guidelines

Skills:

  • Strong analytical and data management skills

  • Attention to detail and commitment to quality

  • Excellent written and verbal communication skills

  • Effective interpersonal and cross-functional collaboration abilities


What ICON Offers

  • Competitive Salary and country-specific benefits

  • Health & Wellness: Comprehensive insurance plans for you and your family

  • Retirement Planning with competitive savings options

  • Paid Time Off: Various annual leave entitlements

  • Employee Assistance Program (EAP): 24/7 global mental health and wellbeing support

  • Flexible Benefits: Optional perks like childcare vouchers, gym discounts, travel passes, and more

  • Inclusive Culture: A strong focus on diversity, equity, inclusion, and belonging

  • Global Opportunities: Room for growth and internal mobility


Additional Information

  • Hiring Manager: Archana Bakkiyarajan

  • Application Options: Apply online or message Archana directly if you have inquiries

  • Accessibility Support: Reasonable accommodations available for candidates with medical conditions or disabilities


How to Apply

Click the Apply button or visit ICON’s Careers Site to submit your application. If you are already an ICON employee, please use the internal application link.


Not sure if you meet all the requirements?
We still encourage you to apply—your unique profile may be exactly what we need, either for this role or another at ICON.